| 66215-814-10 |
66215-814 |
HUMAN PRESCRIPTION DRUG |
OPSYNVI |
macitentan and tadalafil |
TABLET, FILM COATED |
ORAL |
20240322 |
N/A |
NDA |
NDA218490 |
Actelion Pharmaceuticals US, Inc. |
MACITENTAN; TADALAFIL |
10 mg/1; 40 mg/1 |
1 BLISTER PACK in 1 CARTON (66215-814-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (66215-814-01) |
| 66215-814-30 |
66215-814 |
HUMAN PRESCRIPTION DRUG |
OPSYNVI |
macitentan and tadalafil |
TABLET, FILM COATED |
ORAL |
20240322 |
N/A |
NDA |
NDA218490 |
Actelion Pharmaceuticals US, Inc. |
MACITENTAN; TADALAFIL |
10 mg/1; 40 mg/1 |
1 BOTTLE in 1 CARTON (66215-814-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 66215-812-30 |
66215-812 |
HUMAN PRESCRIPTION DRUG |
OPSYNVI |
macitentan and tadalafil |
TABLET, FILM COATED |
ORAL |
20240322 |
N/A |
NDA |
NDA218490 |
Actelion Pharmaceuticals US, Inc. |
MACITENTAN; TADALAFIL |
10 mg/1; 20 mg/1 |
1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 66215-812-08 |
66215-812 |
HUMAN PRESCRIPTION DRUG |
OPSYNVI |
macitentan and tadalafil |
TABLET, FILM COATED |
ORAL |
20240322 |
N/A |
NDA |
NDA218490 |
Actelion Pharmaceuticals US, Inc. |
MACITENTAN; TADALAFIL |
10 mg/1; 20 mg/1 |
1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) |
| 66215-812-07 |
66215-812 |
HUMAN PRESCRIPTION DRUG |
OPSYNVI |
macitentan and tadalafil |
TABLET, FILM COATED |
ORAL |
20240322 |
N/A |
NDA |
NDA218490 |
Actelion Pharmaceuticals US, Inc. |
MACITENTAN; TADALAFIL |
10 mg/1; 20 mg/1 |
1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE |